Quality Assurance Manager – CMO
Aussicht: 160
Update Tag: 25-04-2024
Kategorie: Apotheker / Pharmavertreter
Industrie:
Jobtyp: CDI, Temps de travail : 80-100%
Jobinhalt
Numab Therapeutics AG is an expanding, clinical stage Swiss biotech company based in Wädenswil, Kanton
Zürich. The company is focused on the discovery and development of innovative, antibody fragment-based
therapeutics with a focus on immuno-oncology. With our breakthrough antibody-discovery and multi-specifics
engineering platform, we engage in proprietary projects as well as collaborative research on behalf of partners
in the pharmaceutical industry.
To oversee, foster, and assure the quality of Numab’s contract manufacturing organizations (CMOs) and to
release product for our sponsored clinical development programs, we are looking for a
Quality Assurance Manager – CMO (80-100%)
In this position you will report to the Head Quality Assurance (QA), and you will be responsible for closely working
together with contract manufacturing organizations (CMOs) as Numab expands clinical development with novel
antibody fragment-based immuno-oncology therapies. This role drives the classic QA activities with external and
internal partners: Audits, deviations, OOS, change requests, quality agreements and validation of CMOs. This is
a key role for upholding the organization’s commitment to quality and compliance on a corporate level and
specifically in our sponsored drug manufacturing and clinical development programs.
Your Responsibilities
- Management of all QA requirements of our CMOs
- Liaise with subject matter experts from CMC, Preclinical, Clinical Development and Drug Safety to ensure
the organization’s compliance with applicable GMP regulations
- Manage the QA aspects of a network of suppliers and co-development partners to ensure compliance and
- Build and maintain the CMO quality system and related processes, and provide strategic expertise to
Ideal candidates will have
- Degree in the life sciences or equivalent qualification, with 5+ years of QA experience according to GMP at
- A passion for CMO management and product quality
- Strong understanding of CMO management and underlying processes
- Thorough knowledge of global GMP requirements for all phases of product development through
commercialization; pharmaceutical development/manufacturing of biologics as a plus
- Experience in planning and conducting internal and external audits and regulatory agency inspections, and
- Experience as responsible person (FvP) or willingness to gain such experience
- Ability to work both independently and as part of a team
- Fluency in English as well as strong IT and organizational skills
- Willingness to travel 5%
Are you looking for an inspiring, entrepreneurial atmosphere and want to be part of a dynamic team where your
contributions are both essential and valued? We are looking for skilled and passionate people who are eager to
make an impact. We are offering a permanent position in an innovative environment as well as a competitive
compensation package including a participation in the company.
We are looking forward to receiving your application with reference number NB080 to hr@numab.com.
Numab Therapeutics AG | Einsiedlerstrasse 34 | CH-8820 Wädenswil | Switzerland | www.numab.com
Frist: 09-06-2024
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